药物上市前临床试验安全性评价的局限性及改进建议

doi:10.19803/j.1672-8629.2020.08.04

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (8): 465-470.
DOI: 10.19803/j.1672-8629.2020.08.04

药物上市前临床试验安全性评价的局限性及改进建议

李新旭¹, 唐智敏¹, 周军¹, 王骏^1,*

国家药品监督管理局药品审评中心,北京 100022

收稿日期:2020-07-31 修回日期:2020-07-31 出版日期:2020-08-15 发布日期:2020-07-31
通讯作者: ^*王骏,男,博士,研究员,药品技术审评。E-mail: wangj@cde.org.cn
作者简介:李新旭,男,博士,副研究员,药品技术审评。

Limitations of the Safety Assessment in Premarketing Clinical Trials of Drugs and Suggestions for Improvement

LI Xinxu¹, TANG Zhimin¹, ZHOU Jun¹, WANG Jun^1,*

¹Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China

Received:2020-07-31 Revised:2020-07-31 Online:2020-08-15 Published:2020-07-31
Supported by:
国家“重大新药创制”科技重大专项资助项目（2017ZX09101001）：药物一致性评价关键技术与标准研究

摘要/Abstract

摘要： 目的通过了解药物上市前临床试验安全性评价的局限性,为申办方更加全面、深入和科学地评价药物上市前安全性提供改进建议。方法收集国际上与药物上市前临床试验的安全性评价有关的文献、指导原则、团体建议等,对其有代表性的观点、看法和建议进行归纳分析。结果药物上市前临床试验的安全性评价存在受试者数量和构成不足、不良事件编码不准确、暴露时间易被忽视、因果关系判定困难以及其他局限性。结论建议申办方尽可能完善药物上市前临床试验的安全性评价设计,全面收集安全性信息,合理评估药物暴露时间,适当借助数据可视化,深入分析安全性数据,综合利用安全性证据。

关键词: 上市前评价, 药物临床试验, 安全性, 不良事件, 局限性, 建议

Abstract: Objective To offer recommendations for sponsors on how to assess the safety of premarketing drugs more comprehensively, in more depth and scientifically by outlining the limitations of safety assessment in premarketing clinical trials of drugs. Methods The related literature abroad, guidelines and group recommendations related to the safety assessment in premarketing clinical trials of drugs were collected, while the representative opinions, views and suggestions in these documents were summarized and analyzed. Results The current ways of safety assessment in premarketing clinical trials of drugs have some weaknesses, such as an insufficient number and composition of subjects, inaccurate coding of adverse events, neglect of exposure time, and difficulty in determining causal relationships. Conclusion It is suggested that sponsors should do what they can to improve the design of safety assessment in premarketing clinical trials of drugs, collect as much safety information as possible, evaluate drug exposure time properly, use data visualization appropriately, analyze safety data in depth and make full use of safety evidence.

Key words: premarketing assessment, drug clinical trials, safety, adverse events, limitation, suggestion

中图分类号:

李新旭, 唐智敏, 周军, 王骏. 药物上市前临床试验安全性评价的局限性及改进建议[J]. 中国药物警戒, 2020, 17(8): 465-470.

LI Xinxu, TANG Zhimin, ZHOU Jun, WANG Jun. Limitations of the Safety Assessment in Premarketing Clinical Trials of Drugs and Suggestions for Improvement[J]. Chinese Journal of Pharmacovigilance, 2020, 17(8): 465-470.

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药物上市前临床试验安全性评价的局限性及改进建议

Limitations of the Safety Assessment in Premarketing Clinical Trials of Drugs and Suggestions for Improvement

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